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gynuity  CREP1 Treatment of Postpartum Hemorrhage with Misoprostol:
  Who do we treat? Who will develop fever?


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This study seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals representative of different regions of Latin America to explore environmental and genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss, pulse and blood pressure will be systematically measured for all women enrolled to explore new clinical indicators for identifying women who require clinical intervention for excessive bleeding.

Research Objectives
1. To document rates of high fever (≥40.0°C) following first-line PPH treatment with sublingual misoprostol (800mcg).  [Primary  Outcome]
2. To characterize the side effect profile of misoprostol for treatment of postpartum hemorrhage, in particular shivering and fever. 3. To determine whether the regimen and side effect profile are acceptable to women.
4. To determine the relationship between postpartum changes in shock index and severity of blood loss and other PPH outcomes. 5. To investigate genetic factors responsible for elevated body temperature induced by misoprostol.



Pharmacogenomics of misoprostol for the treatment of postpartum haemorrhage | Alfirevic A; Durocher J; León W; Radisch S; Dickens D; Weeks A; Winikoff B


Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial |
Jennifer Blum, Beverly Winikoff , Sheila Raghavan, Rasha Dabash, Mohamed Cherine Ramadan, Berna Dilbaz, Blami Dao, Jill Durocher,Serdar Yalvac, Ayisha Diop, Ilana G Dzuba, Nguyen Thi Nhu Ngoc


High fever following postpartum administration of sublingual misoprostol |
J Durocher,a J Bynum,a W Leo´ n,b G Barrera,b B Winikoffa


A systematic review of the relationship between blood loss and clinical signs.
Pacagnella RC1, Souza JP, Durocher J, Perel P, Blum J, Winikoff B, Gülmezoglu AM


Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial | Beverly Winikoff MD, Rasha Dabash MPH, Jill Durocher, Prof Emad Darwish MD, Nguyen Thi Nhu Ngoc MD, Wilfrido León MD, Sheila Raghavan MSc, Prof Ibrahim Medhat MD, Huynh Thi Kim Chi MD, Gustavo Barrera MD, Jennifer Blum MPH